University of Rochester Medical Center (URMC) researchers have been selected as part of a national initiative by the National Institutes of Health (NIH) to develop new non-addictive treatments for pain to improve patient care and curb the use and abuse of opioids.
The URMC awards are part of a $945 million in grants recently announced under the NIH Helping to End Addiction Long-term Initiative (NIH HEAL), which was created to improve treatments for chronic pain, reduce opioid use disorder and overdoses, and achieve long-term recovery from opioid addiction. This initiative represents the largest ever financial commitment by NIH to a single research program.
It is estimated that 50 million adults in the U.S. suffer from chronic pain and 10 million people misuse opioids, including heroin. More than 400,000 Americans have died from overdoses of prescription pain narcotics, heroin, and fentanyl since 1999.
URMC researchers have been selected to carry out clinical trials for new non-addictive pain therapies and provide national leadership to the NIH Early Phase Pain Investigation Clinical Network (EPPIC-Net), which consists of clinical research experts from across different specialties in academia, foundations, and industry.
One URMC project will be led by John Markman, M.D., director of the Department of Neurosurgery’s Translational Pair Research Program and Jennifer Gewandter, Ph.D., M.P.H., assistant professor in the Department of Anesthesiology and Perioperative Medicine. The Medical Center will serve as a hub for a group of institutions that includes the Children’s Hospitals and Clinics of Minnesota, the University of Miami, Rutgers University, and the Carolinas Pain Institute that will conduct clinical trials for new pain relief therapies. Thirteen dedicated principal investigators at URMC will recruit subjects with a broad range of pain conditions from anesthesiology, dentistry, emergency medicine, gastroenterology, gynecology, neurology, neurosurgery, oncology, orthopedics, pediatrics, rheumatology, and urology.
The URMC-led project is one of 12 hub-and-spoke research clusters chosen as part of the NIH EPPIC-Net program.
“The urgency to develop more effective and safer pain treatments has never been greater,” said Markman. “This initiative will enable us to better understand chronic pain mechanisms and the biologic basis for different pain conditions and why some patients respond differently to pain treatments.”
“Chronic pain is a devastating condition with only a few classes of modestly effective treatments available and they often come with intolerable side effects,” said Gewandter. “Very little progress has been made in developing analgesics with novel mechanisms in recent decades and, as a result, clinicians and patients have relied heavily on opioids to manage chronic pain. An established infrastructure of dedicated and experienced pain researchers is a critical resource to expedite the investigation of potential novel analgesics that would otherwise not be pursued.”
Robert Dworkin, Ph.D., a professor in the Departmenta of Anesthesiology and Perioperative medicine, neuro, and Psychiatry will serve as one of the principal investigators of the EPPIC-Net Clinical Coordinating Center (CCC), which will provide the overall scientific leadership for the design and conduct of the clinical trials that will be conducted by the 12 research clusters.
“NIH HEAL represents an historic and unprecedented effort on behalf of the federal government and the medical community to improve pain management, reduce prescription drug abuse, and help combat the opioid crisis,” said Dworkin. “By leveraging public and private expertise from across a broad spectrum of pain research, this initiative will help accelerate the process of bringing new analgesic drugs and devices to the clinic.”
The Medical Center’s Clinical Materials Services Unit, which is part of the Center for Health + Technology and led by senior research associate Cornelia Kamp, M.B.A., will also provide support to the CCC by providing clinical supply chain management, packaging, labeling, distribution, and return services of drugs and devices used in EPICC-Net clinical studies.
Markman founded the Translational Pain Research Program in 2007. Since its inception, he has led more than 45 multi-center clinical trials in chronic pain study populations. Dworkin, Gewandter, and Kamp are director, assistant director, and program manager, respectively, of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the U.S. Food and Drug Administration (FDA) that was established in 2010 to improve the discovery and development of improved analgesic, anesthetic, addiction, and peripheral neuropathy treatments.